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Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer

Clinical Trial Summary

Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Clinical Trial Description

A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or metastatic breast cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02207335
Study type Interventional
Source Tianjin Medical University Cancer Institute and Hospital
Contact Zhongsheng Tong, Master
Phone +86 18622221181
Email 18622221181@163.com
Status Recruiting
Phase Phase 3
Start date December 2013
Completion date December 2016
View Details
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